Radiation Therapy Cisplatin With or Without Fluorouracil Patients With Stage III or Stage IV Head and Neck Cancer

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Number of patients that are alive without recurrence when recurrence i...

Description

Number of patients that are alive without recurrence when recurrence is defined by any subject with new evidence of cancer after achieving a complete response. Complete response is defined by the complete disappearance of all clinically and radiologically detectable tumor..

Time Frame

at 2 yrs from start of study

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

intention to treat (ITT)

Arm/Group Title

Arm A

Arm B

Arm/Group Description:

Patients undergo full-dose radiothe...

Patients undergo radiotherapy as in...

Arm/Group Description:

Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.

Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Overall Number of Participants Analyzed

35

34

Measure Type: Number

Unit of Measure: participants

30

28

2.Secondary Outcome

Title

Patterns of Failure

Description

Patients with any new evidence of cancer after achieving a complete re...

Description

Patients with any new evidence of cancer after achieving a complete response are considered to have recurrent disease. Biopsy verification will be obtained if at all possible and salvage surgery is recommended if possible. Disease recurrence will be characterized as either local, regional(nodal) or distant recurrence. Patients may have more than one kind of recurrence.

Time Frame

2 years from start of study

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

intention to treat (ITT)

Arm/Group Title

Arm A

Arm B

Arm/Group Description:

Patients undergo full-dose radiothe...

Patients undergo radiotherapy as in...

Arm/Group Description:

Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.

Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Overall Number of Participants Analyzed

35

34

Measure Type: Number

Unit of Measure: participants

Local recurrence

1

1

Regional (nodal) recurrence

1

0

Distant recurrence

4

4

3.Secondary Outcome

Title

Overall Survival

Description

Number of patients still alive from 2 years from start of study

Description

Number of patients still alive from 2 years from start of study

Time Frame

2 yrs from start of study

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

intention to treat (ITT)

Arm/Group Title

Arm A

Arm B

Arm/Group Description:

Patients undergo full-dose radiothe...

Patients undergo radiotherapy as in...

Arm/Group Description:

Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.

Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Overall Number of Participants Analyzed

35

34

Measure Type: Number

Unit of Measure: participants

34

29

4.Secondary Outcome

Title

Number of Patients With a Clinical Response-complete Disappearance of Detectable Tumor

Twelve weeks after completing chemoradiotherapy, a formal evaluation for response will be made, to include a careful evaluation by the head and neck surgeon, medical and radiation oncologists, and, as appropriate, a radiologic and an endoscopic examination. Patients will be considered to have achieved either a clinical complete response (i.e. complete disappearance of all clinically and radiologically detectable tumor) or to have clinical persistent disease.

Time Frame

at 12 weeks after completing chemoradiotherapy

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

intention to treat (ITT)

Arm/Group Title

Arm A

Arm B

Arm/Group Description:

Patients undergo full-dose radiothe...

Patients undergo radiotherapy as in...

Arm/Group Description:

Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.

Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Overall Number of Participants Analyzed

35

34

Measure Type: Number

Unit of Measure: participants

35

28

5.Secondary Outcome

Title

Number of Patients With a Pathological(Final)Complete Response

Description

A Pathological, or final response will be assigned to subjects after a...

Description

A Pathological, or final response will be assigned to subjects after any salvage surgery is performed for clinical persistent disease, and after planned neck dissection in those achieving a clinical complete response. If no surgery is performed after chemoradiotherapy, the clinical and pathological (final) response will be the same. Patient will be coded as having either a pathologic complete response, or as having pathologic persistent disease. A pathologic complete response will be defined as the total disappearance of all clinically and radiologically detectable tumor.

Time Frame

at 12 weeks after completing chemoradiotherapy and surgery

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm A

Arm B

Arm/Group Description:

Patients undergo full-dose radiothe...

Patients undergo radiotherapy as in...

Arm/Group Description:

Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.

Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Overall Number of Participants Analyzed

35

34

Measure Type: Number

Unit of Measure: participants

35

31

6.Secondary Outcome

Title

Disease Recurrence

Description

Number of patients with any new evidence of cancer after achieving a c...

Description

Number of patients with any new evidence of cancer after achieving a complete response (at 12 weeks after completing chemoradiotherapy) are considered to have recurrent disease.

Time Frame

2 years after start of study

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

Patients that had a complete response after 12 weeks of therapy

Arm/Group Title

Arm A

Arm B

Arm/Group Description:

Patients undergo full-dose radiothe...

Patients undergo radiotherapy as in...

Arm/Group Description:

Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.

Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Overall Number of Participants Analyzed

35

31

Measure Type: Number

Unit of Measure: participants

5

2

7.Secondary Outcome

Title

Number of Patients That Required a Feeding Tube

Description

[Not Specified]

Description

[Not Specified]

Time Frame

12 weeks (after treatment)

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Arm/Group Title

Arm A

Arm B

Arm/Group Description:

Patients undergo full-dose radiothe...

Patients undergo radiotherapy as in...

Arm/Group Description:

Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.

Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Overall Number of Participants Analyzed

29

26

Measure Type: Number

Unit of Measure: participants

0

3

8.Secondary Outcome

Title

Number of Patients That Required a Feeding Tube

Description

[Not Specified]

Description

[Not Specified]

Time Frame

8 months after start of treatment

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Arm/Group Title

Arm A

Arm B

Arm/Group Description:

Patients undergo full-dose radiothe...

Patients undergo radiotherapy as in...

Arm/Group Description:

Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.

Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Overall Number of Participants Analyzed

28

24

Measure Type: Number

Unit of Measure: participants

0

0

9.Secondary Outcome

Title

Number of Patients That Required a Feeding Tube

Description

[Not Specified]

Description

[Not Specified]

Time Frame

12 months after start of treatment

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Arm/Group Title

Arm A

Arm B

Arm/Group Description:

Patients undergo full-dose radiothe...

Patients undergo radiotherapy as in...

Arm/Group Description:

Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.

Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Overall Number of Participants Analyzed

28

23

Measure Type: Number

Unit of Measure: participants

0

0

10.Secondary Outcome

Title

Number of Patients That Required a Feeding Tube

Description

[Not Specified]

Description

[Not Specified]

Time Frame

24 months after start of treatment

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Arm/Group Title

Arm A

Arm B

Arm/Group Description:

Patients undergo full-dose radiothe...

Patients undergo radiotherapy as in...

Arm/Group Description:

Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.

Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Overall Number of Participants Analyzed

21

17

Measure Type: Number

Unit of Measure: participants

0

0

11.Secondary Outcome

Title

Nausea Level

Description

Quality of life question...

Description

Quality of life questionnaire asking "I have nausea".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4).

N (number of patients analyzed) is based on number of patients who completed the question.

Time Frame

12 weeks (after treatment)

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Arm/Group Title

Arm A

Arm B

Arm/Group Description:

Patients undergo full-dose radiothe...

Patients undergo radiotherapy as in...

Arm/Group Description:

Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.

Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Overall Number of Participants Analyzed

28

26

Mean (Standard Deviation)

Unit of Measure: units on a scale

0.07
(0.26)

0.12
(0.33)

12.Secondary Outcome

Title

Nausea Level

Description

Quality of life question...

Description

Quality of life questionnaire asking "I have nausea".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.

Time Frame

8 months from start of treatment

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Arm/Group Title

Arm A

Arm B

Arm/Group Description:

Patients undergo full-dose radiothe...

Patients undergo radiotherapy as in...

Arm/Group Description:

Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.

Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Overall Number of Participants Analyzed

27

23

Mean (Standard Deviation)

Unit of Measure: units on a scale

0.15
(0.46)

0.09
(0.29)

13.Secondary Outcome

Title

Nausea Level

Description

Quality of life question...

Description

Quality of life questionnaire asking "I have nausea".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.

Time Frame

12 months from start of treatment

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Arm/Group Title

Arm A

Arm B

Arm/Group Description:

Patients undergo full-dose radiothe...

Patients undergo radiotherapy as in...

Arm/Group Description:

Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.

Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Overall Number of Participants Analyzed

28

23

Mean (Standard Deviation)

Unit of Measure: units on a scale

0.14
(0.45)

0.04
(0.21)

14.Secondary Outcome

Title

Nausea Level

Description

Quality of life questionnaire asking "I have nausea".

Description

Quality of life questionnaire asking "I have nausea".

Time Frame

24 months from start of treatment

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Arm/Group Title

Radiation With Concurrent Cisplatin

Radiation With Concurrent 5-FU and Cisplatin

Arm/Group Description:

Patients undergo full-dose radiothe...

Patients undergo radiotherapy as in...

Arm/Group Description:

Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.

Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Overall Number of Participants Analyzed

21

16

Mean (Standard Deviation)

Unit of Measure: units on a scale

0.10
(0.3)

0
(0)

15.Secondary Outcome

Title

Dry Mouth

Description

Quality of life question...

Description

Quality of life questionnaire asking "My mouth is dry".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.

Time Frame

12 weeks (after treatment)

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Arm/Group Title

Arm A

Arm B

Arm/Group Description:

Patients undergo full-dose radiothe...

Patients undergo radiotherapy as in...

Arm/Group Description:

Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.

Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Overall Number of Participants Analyzed

27

25

Mean (Standard Deviation)

Unit of Measure: units on a scale

3.33
(0.83)

3.08
(1.15)

16.Secondary Outcome

Title

Dry Mouth

Description

Quality of life question...

Description

Quality of life questionnaire asking "My mouth is dry".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.

Time Frame

8 months from start of treatment

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Arm/Group Title

Arm A

Arm B

Arm/Group Description:

Patients undergo full-dose radiothe...

Patients undergo radiotherapy as in...

Arm/Group Description:

Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.

Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Overall Number of Participants Analyzed

27

23

Mean (Standard Deviation)

Unit of Measure: units on a scale

2.67
(1.07)

3.09
(0.85)

17.Secondary Outcome

Title

Dry Mouth

Description

Quality of life question...

Description

Quality of life questionnaire asking "My mouth is dry".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.

Time Frame

12 months from start of treatment

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Arm/Group Title

Arm A

Arm B

Arm/Group Description:

Patients undergo full-dose radiothe...

Patients undergo radiotherapy as in...

Arm/Group Description:

Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.

Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Overall Number of Participants Analyzed

27

22

Mean (Standard Deviation)

Unit of Measure: units on a scale

2.70
(1.03)

3.09
(0.92)

18.Secondary Outcome

Title

Dry Mouth

Description

Quality of life question...

Description

Quality of life questionnaire asking "My mouth is dry".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.

Time Frame

24 months from start of treatment

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Arm/Group Title

Arm A

Arm B

Arm/Group Description:

Patients undergo full-dose radiothe...

Patients undergo radiotherapy as in...

Arm/Group Description:

Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.

Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Overall Number of Participants Analyzed

20

16

Mean (Standard Deviation)

Unit of Measure: units on a scale

2.60
(1.10)

2.94
(1.29)

19.Secondary Outcome

Title

Pain

Description

Quality of life question...

Description

Quality of life questionnaire asking "I have pain in my mouth, throat or neck".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.

Time Frame

12 weeks (after treatment)

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Arm/Group Title

Arm A

Arm B

Arm/Group Description:

Patients undergo full-dose radiothe...

Patients undergo radiotherapy as in...

Arm/Group Description:

Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.

Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Overall Number of Participants Analyzed

29

26

Mean (Standard Deviation)

Unit of Measure: units on a scale

1.24
(1.06)

1.42
(0.95)

20.Secondary Outcome

Title

Pain

Description

Quality of life question...

Description

Quality of life questionnaire asking "I have pain in my mouth, throat or neck".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.

Time Frame

8 months from start of treatment

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Arm/Group Title

Arm A

Arm B

Arm/Group Description:

Patients undergo full-dose radiothe...

Patients undergo radiotherapy as in...

Arm/Group Description:

Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.

Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Overall Number of Participants Analyzed

26

23

Mean (Standard Deviation)

Unit of Measure: units on a scale

0.65
(0.80)

0.74
(0.81)

21.Secondary Outcome

Title

Pain

Description

Quality of life question...

Description

Quality of life questionnaire asking "I have pain in my mouth, throat or neck".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.

Time Frame

12 months from start of treatment

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Arm/Group Title

Arm A

Arm B

Arm/Group Description:

Patients undergo full-dose radiothe...

Patients undergo radiotherapy as in...

Arm/Group Description:

Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.

Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Overall Number of Participants Analyzed

28

23

Mean (Standard Deviation)

Unit of Measure: units on a scale

0.57
(0.74)

0.57
(0.79)

22.Secondary Outcome

Title

Pain

Description

Quality of life question...

Description

Quality of life questionnaire asking "I have pain in my mouth, throat or neck".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.

Time Frame

24 months from start of treatment

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Arm/Group Title

Arm A

Arm B

Arm/Group Description:

Patients undergo full-dose radiothe...

Patients undergo radiotherapy as in...

Arm/Group Description:

Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.

Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Overall Number of Participants Analyzed

20

16

Mean (Standard Deviation)

Unit of Measure: units on a scale

0.60
(0.75)

0.75
(1.00)

23.Secondary Outcome

Title

Quality of Life

Description

Quality of life question...

Description

Quality of life questionnaire asking "I am content with the quality of my life right now".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.

Time Frame

12 weeks (after treatment)

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Arm/Group Title

Arm A

Arm B

Arm/Group Description:

Patients undergo full-dose radiothe...

Patients undergo radiotherapy as in...

Arm/Group Description:

Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.

Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Overall Number of Participants Analyzed

27

25

Mean (Standard Deviation)

Unit of Measure: units on a scale

1.37
(1.08)

1.68
(1.14)

24.Secondary Outcome

Title

Quality of Life

Description

Quality of life question...

Description

Quality of life questionnaire asking "I am content with the quality of my life right now".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.

Time Frame

8 months from start of treatment

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Arm/Group Title

Arm A

Arm B

Arm/Group Description:

Patients undergo full-dose radiothe...

Patients undergo radiotherapy as in...

Arm/Group Description:

Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.

Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Overall Number of Participants Analyzed

27

23

Mean (Standard Deviation)

Unit of Measure: units on a scale

0.85
(1.13)

1.13
(1.18)

25.Secondary Outcome

Title

Quality of Life

Description

Quality of life question...

Description

Quality of life questionnaire asking "I am content with the quality of my life right now".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.

Time Frame

12 months from start of treatment

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Arm/Group Title

Arm A

Arm B

Arm/Group Description:

Patients undergo full-dose radiothe...

Patients undergo radiotherapy as in...

Arm/Group Description:

Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.

Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Overall Number of Participants Analyzed

27

22

Mean (Standard Deviation)

Unit of Measure: units on a scale

0.67
(1.00)

0.95
(0.84)

26.Secondary Outcome

Title

Quality of Life

Description

Quality of life question...

Description

Quality of life questionnaire asking "I am content with the quality of my life right now".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.

Time Frame

24 months from start of treatment

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Arm/Group Title

Arm A

Arm B

Arm/Group Description:

Patients undergo full-dose radiothe...

Patients undergo radiotherapy as in...

Arm/Group Description:

Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.

Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Overall Number of Participants Analyzed

21

16

Mean (Standard Deviation)

Unit of Measure: units on a scale

0.62
(0.86)

0.88
(0.81)

27.Secondary Outcome

Title

Eating

Description

Quality of life question...

Description

Quality of life questionnaire asking "I am able to eat the foods i like".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.

Time Frame

12 weeks (after treatment)

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Arm/Group Title

Arm A

Arm B

Arm/Group Description:

Patients undergo full-dose radiothe...

Patients undergo radiotherapy as in...

Arm/Group Description:

Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.

Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Overall Number of Participants Analyzed

27

25

Mean (Standard Deviation)

Unit of Measure: units on a scale

2.33
(1.07)

2.28
(1.02)

28.Secondary Outcome

Title

Eating

Description

Quality of life question...

Description

Quality of life questionnaire asking "I am able to eat the foods i like".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.

Time Frame

8 months from start of treatment

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Arm/Group Title

Arm A

Arm B

Arm/Group Description:

Patients undergo full-dose radiothe...

Patients undergo radiotherapy as in...

Arm/Group Description:

Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.

Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Overall Number of Participants Analyzed

27

23

Mean (Standard Deviation)

Unit of Measure: units on a scale

1.93
(1.17)

1.78
(0.95)

29.Secondary Outcome

Title

Eating

Description

Quality of life question...

Description

Quality of life questionnaire asking "I am able to eat the foods i like".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.

Time Frame

12 months from start of treatment

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Arm/Group Title

Arm A

Arm B

Arm/Group Description:

Patients undergo full-dose radiothe...

Patients undergo radiotherapy as in...

Arm/Group Description:

Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.

Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Overall Number of Participants Analyzed

27

21

Mean (Standard Deviation)

Unit of Measure: units on a scale

1.56
(1.25)

1.24
(1.09)

30.Secondary Outcome

Title

Eating

Description

Quality of life question...

Description

Quality of life questionnaire asking "I am able to eat the foods i like".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.

Time Frame

24 months from start of treatment

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Arm/Group Title

Arm A

Arm B

Arm/Group Description:

Patients undergo full-dose radiothe...

Patients undergo radiotherapy as in...

Arm/Group Description:

Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.

Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Overall Number of Participants Analyzed

21

16

Mean (Standard Deviation)

Unit of Measure: units on a scale

1.52
(1.17)

1.13
(1.09)

31.Secondary Outcome

Title

Swallowing

Description

Quality of life question...

Description

Quality of life questionnaire asking "I can swallow naturally and easily".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.

Time Frame

12 weeks (after treatment)

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Arm/Group Title

Arm A

Arm B

Arm/Group Description:

Patients undergo full-dose radiothe...

Patients undergo radiotherapy as in...

Arm/Group Description:

Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.

Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Overall Number of Participants Analyzed

29

26

Mean (Standard Deviation)

Unit of Measure: units on a scale

1.93
(1.07)

2.31
(0.97)

32.Secondary Outcome

Title

Swallowing

Description

Quality of life question...

Description

Quality of life questionnaire asking "I can swallow naturally and easily".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.

Time Frame

8 months after start of treatment

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Arm/Group Title

Arm A

Arm B

Arm/Group Description:

Patients undergo full-dose radiothe...

Patients undergo radiotherapy as in...

Arm/Group Description:

Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.

Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Overall Number of Participants Analyzed

26

23

Mean (Standard Deviation)

Unit of Measure: units on a scale

1.31
(1.12)

1.83
(1.03)

33.Secondary Outcome

Title

Swallowing

Description

Quality of life question...

Description

Quality of life questionnaire asking "I can swallow naturally and easily".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.

Time Frame

12 months after start of treatment

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Arm/Group Title

Arm A

Arm B

Arm/Group Description:

Patients undergo full-dose radiothe...

Patients undergo radiotherapy as in...

Arm/Group Description:

Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.

Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Overall Number of Participants Analyzed

28

23

Mean (Standard Deviation)

Unit of Measure: units on a scale

1.61
(1.13)

1.52
(1.16)

34.Secondary Outcome

Title

Swallowing

Description

Quality of life question...

Description

Quality of life questionnaire asking "I can swallow naturally and easily".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.

Time Frame

24 months after start of treatment

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.

Arm/Group Title

Arm A

Arm B

Arm/Group Description:

Patients undergo full-dose radiothe...

Patients undergo radiotherapy as in...

Arm/Group Description:

Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.

Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.